Health Condition 1: F418- Other specified anxiety disorders
Conditions
Interventions
Intervention1: Nill: Nill
Intervention2: Escitalopram: 5mg, 10mg, 20mg (FELIZ-S)
Vortioxetine: 5mg, 10 mg, 20mg (VOXIGAIN/TORVOX)
Clonazepam: 0.5 mg (CLONOTRIL): Dosage Form: tablets
Route of administ
Sponsors
TORRENT PHARMA
Eligibility
Inclusion criteria
Inclusion criteria: Male or female patients 18 to 65 years with DSM-V defined MDD with anxious depression. Treatment naïve patients or known cases already on VOR or ESC not exceeding two weeks of active treatment. ? Patients with MADRS score is greater than 20 and HAM-A score is greater than 25. Patient with normal physical examination clinical laboratory and ECG findings (as per physicians discretion) Patients who are willing to sign the informed consent form
Exclusion criteria
Exclusion criteria: Patient aged less than 18 years and more than 65 years will be excluded. Patient with MADRS less than 19 and HAM-A less than 24. Patients requiring second generation antipsychotics or lithium. Patient in which the use of benzodiazepine is contraindicated. Patient with other conditions who do not fit into the criteria of the study as per the protocol. Patient with known hypersensitivity to Vortioxetine, Escitalopram, Clonazepam or any excipients. Patients who are not willing to sign the informed consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to 2 and 6 week. Change in Hamilton Anxiety Rating Scale for Anxiety (HAM –A) total scores from baseline to 2 and 6 week.Timepoint: 2 and 6 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impression for Efficacy Index (CGI-EI) at 2 and 6 Week Treatment Emergent Adverse event (TEAE) assessment at every scheduled visit Change in Sexual function or ASEX score from baseline to 2 week and 6 weekTimepoint: 2 and 6 weeks | — |
Countries
India
Contacts
Public ContactDr Krishnaprasad K
Asha Hospital
Outcome results
None listed